Religious debate [Regulatives / Guidelines]

posted by nobody – 2016-02-14 16:23 (3285 d 13:01 ago) – Posting: # 15990
Views: 19,923

Hi Danmark :-D

❝ PK in drug development is all about impressing the assessor with complex models having a million effect estimates of dubious value. It is not about making sense. Just sayin'...


I heard in the past that each and every piece of modeling (wherever submitted in the EU when any kind of non-national marketing authorization is applied for) is going for review to Sweden.

I would not build any relevant argumentation on models clearly identifiable as nonsense in this situation, huh? ;-)

Kindest regards, nobody

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